Quality Smart Solutions ensures your labels meet DSHEA and 21 CFR code of federal regulations. We review your labels, advise on structure-function claims, prepare a substantiation dossier (if required) and file a pre-market notification with FDA . We guide you to market your products, and stay compliant with FDA regulations.
Dietary supplements are health and wellness products that contain dietary ingredients, including minerals, vitamins, herbs, amino acids, botanicals, and other categories of ingredients that can be used to supplement diets. The forms of dietary supplements include but are not limited to tablets, powders, capsules, gummies and liquids. The supplements are used to improve health, used for prevention of ailments and and for the maintenance of overall wellness.
Based on the CRN Consumer Survey on Dietary Supplements conducted in 2019, 77% of Americans consume dietary supplements. The majority of both are males and females, aged 18+ years. Among the age groups, adults between the ages of 35 – 54 years share 18% consumption, the highest usage of dietary supplements. Consequently, the nutritional supplement industry is witnessing massive growth, primarily in vitamins and protein supplements.
FDA governs Dietary Supplements. FTC governs the marketing and advertisement of dietary supplements. Failure to comply with the regulations can result in FDA warning letter issuance, FTC fines, stop sale, recall and potential litigation. If you exporting dietary supplements to the United States it may result in entry refusal and the U.S. Customs and Border Protection detaining your goods. As a manufacturer, importer, or distributor of dietary supplements and dietary ingredients, you’re solely responsible for assessing the safety and labeling of your products. You must ensure products adhere to all the requirements of FDA and DSHEA regulations. Here are a list of requirements to keep in mind for your dietary supplement.
You must follow the labeling requirements, such as nutrition labeling, ingredient labeling, and nutrient content, health claims, dietary supplement packaging regulations, etc.
Having a ‘Supplement Facts Panel’ is mandatory for every dietary supplement to be marketed in USA. The panel must have all information required by FDA.
According to Federal Food, Drug, and Cosmetic Act, FDA must be notified within 30 days of your dietary supplement first marketed in USA.
FDA and FTC require health claims about the safety of your dietary supplements that must be supported with reliable scientific evidence.
Proven Expertise. Companies who have Trusted Us to Become Regulatory Compliant with FDA
We have reviewed a wide range of Dietary Supplement Product Labels, including but not limited to the following.
Our team consists of professionals who have extensive FDA Dietary Supplement, Food, Pharma, Medical Device, and Drug regulatory, licensing experience having reviewed over 1500 dietary supplement labels.
Our US regulatory specialists will review your label, Supplement Facts Panel (SFP), Structure-function claims, and give suggestions to meet labeling requirements and ensure SFP is in the correct format
Our officers will assist you in creating Supplement Facts Panel with adequate attention to box, font, thickness, etc., and ensure it strictly adheres to the required format and remain print-ready.
We will empower you to prepare dossiers for supporting the efficacy and safety of your dietary ingredients according to the standards of evidence as described in the Federal Act.
Do not worry about structure-function claim notification as our specialists will assist you in preparing the structure-function claim notification and submitting it through mail or electronically.
We cater to all criteria required to serve as a US agent. With expert knowledge and extensive experience, we are able to answer every question the FDA may have in case of an emergency.
Our US Regulatory experts will help you register or renew your food or dietary supplement facility with FDA. We make the entire registration and renewal process simple and cost-effective
We determine if your ingredient is a New Dietary Ingredient, prepare a full dossier for a New Dietary Ingredient Notification, request for FDA pre-submission meeting, and address any questions asked by the FDA.
If you are shipping dietary supplements into the United States a Prior Notice must be filed prior to arrival. An FDA confirmation with a bar code must accompany most dietary supplements at port of entry.
Follow Latest News, Blogs & Industry Updates
How to Minimize the Risk of Border Detention Shipping Consumer Packaged Goods As an importer of consumer packaged goods, unanticipated delays at the border will
... Read more
Inspection of your food facility will help identify and fix any quality or processing deviations found regarding food safety. Review of the processes and procedures
... Read more
What is Hemp Seed Oil categorized as in Canada? In Canada, Hemp (Cannabis Sativa) seed oil can be categorized as a Natural Health Product (NHP),
... Read more
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually between October 1st and December
... Read morePlease complete the form below. We will respond to you soon.
